RCS - Argent Biopharma Ltd - CannEpil - Technical Overview

Argent BioPharmaAnnouncement

10/09/2024 07:00

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RNS Number : 5098D  Argent Biopharma Limited  10 September 2024

 

10 September 2024

 

Argent BioPharma Ltd.

(Argent BioPharma or the Company)

 

CannEpil®

 

CannEpil®, one of Argent BioPharma's flagship products, is an enhanced
iteration of a compounded isolated cannabinoid formulation. It leverages
well-known historical data to become one of the first compounded prescription
investigational drugs used for seizure management over the past years. The
active ingredients in this formulation include two isolated cannabinoids, each
dissolved in a liquid solution.

While the 'Food and Drug Administration' in the USA (FDA) has already approved
the use of cannabidiol alone for treating seizures in a few rare conditions,
CannEpil® as a compounded formulation may offer additional advantages.
Different combinations have shown a synergistic effect in animal models of
seizures, enabling improved control with significantly lower doses.

However, different cannabinoid combinations have not yet been thoroughly
studied for the treatment of seizure disorders in well-controlledclinical
trials. This is due to several factors, with the primary challenge being the
lack of rigorous standardization.

This is where our research and development efforts come into play: We adhere
to strict standard procedures for sourcing the raw materials, produce them in
a 'Good Manufacturing Practice' (GMP)-certified facility by the national
Competent  Health Authorities using compliant processes, and thus have a
rigorously manufactured, stable, effective and quality product branded as
CannEpil® at our disposal.

Early clinical data has been gathered from the use of CannEpil® in the
treatment of epilepsy through Australia's and Ireland's Special Access Scheme
programs. Two key findings have emerged from this initial experience:

·    CannEpil® was prescribed at 28-35% lower doses compared to the
CBD-only drug it was compared with, demonstrating its potent efficacy.

·    The retention rate, or continued prescription use, for CannEpil® was
observed to be higher than that of the CBD-only counterpart, potentially
indicating an improved safety profile alongside enhanced efficacy.

We are currently addressing the preclinical and clinical gaps in knowledge and
data as part of the pathway to registering CannEpil® and obtaining a
marketing authorization. These activities include completing the missing
toxicology data through pre-clinical studies in the upcoming quarters. This
will be followed by initial clinical trials to establish the pharmacokinetics
of CannEpil® in humans and early-phase efficacy trials.

A few haphazard comments may be added in favor of CannEpil®:

Clinical

·    Combined cannabinoid treatments have been occasionally observed to
rescue seizure control after the failure of pure CBD therapies. This opens the
possibility that CannEpil® might be effective in patients with
treatment-resistant epilepsy who have failed treatment with CBD-alone or other
approved, conventional treatments.

·    Isolated reports indicate that treatment with cannabinoid
combinations is associated with significantly less liver toxicity as compared
to the most common pure-CBD only preparation.

·    The absence of any sugar in CannEpil® renders it as an acceptable
add-on treatment in patients maintaining a ketogenic diet; and

·    A randomized controlled trial on 31 healthy participants was
completed, and the effect of acute dosing with CannEpil® on driving skills
was assessed. The results are compatible with a good safety profile.

Markets

·    Ireland: In 2019, CannEpil® became eligible for patients in Ireland
and fully covered under Ireland's Primary Care Reimbursement Service as part
of the country's Medicinal Cannabis Access Program (MCAP). In 2021, the Irish
Health Service Executive (HSE) extended its support by including CannEpil® in
its reimbursement scheme under the Special Access Program. This inclusion
allows patients to access CannEpil® without bearing the full financial
burden, significantly enhancing its accessibility for those in need;

·    UK: in early 2023, CannEpil® was introduced into the UK and made
available through the "Named Patient Request" system, a specialized mechanism
that allows healthcare professionals on the General Medical Council (GMC)
Specialist Register to prescribe it for patients with severe,
treatment-resistant epilepsy. The approval for CannEpil®'s importation and
prescription in the UK has been granted by the Medicines and Healthcare
products Regulatory Agency (MHRA);

·    The UK National Health Service's Refractory Epilepsy Specialist
Clinical Advisory Service (RESCAS) affords support by ensuring access to
innovative treatments, such as CannEpil®, that can provide hope and improve
outcomes for patients with challenging medical conditions;

·    The value of this avenue is illustrated by the successful treatment
of "patient M" who gained access to CannEpil® thanks to support from the 'I
AM Billy Foundation'. The real-world data gathered in this case highlights the
transformative potential of CannEpil® in managing refractory epilepsy, with a
remarkable reduction in seizures and improved quality of life observed after
1.5 years of treatment. Beyond seizure control, patient M has experienced
enhancements in cognitive function, motor skills (fine and gross), speech, and
sleep patterns;

·    Argent BioPharma is assessing CannEpil® clinical development program
in the UK, with ongoing real-world data collection to gather further data on
its safety and efficacy; and

·    USA: In 2024, the company began a pre-IND process with the FDA,
leading to getting assigned with  an Investigational New Drug (IND) number.
This move positions CannEpil® for potential entry into the US market,
contingent upon successful clinical outcomes.

 

In 2024, as part of a strategic restructuring into Argent BioPharma, the
company temporarily paused its clinical trials to reassess and refine the
regulatory pathway for CannEpil®. This restructuring aims to incorporate
additional intellectual property (IP) protections and potential commercial
safeguards, ensuring the drug's long-term viability and market
competitiveness.

Argent BioPharma's current efforts include submitting an Orphan Drug
Designation (ODD) application with the FDA, with another application in the
conceptualization phase. Additionally, Argent BioPharma's medical team is
exploring a unique indication associated with a novel mechanism of action,
which is believed to hold significant potential for an IP claim.

To summarize, by leveraging insights from the Pre-IND dialogues and emerging
data, particularly from UK case studies, Argent BioPharma aims to establish a
new clinical development pathway for CannEpil®.  These efforts are designed
to position Argent BioPharma favorably within the regulatory landscape,
creating an enhanced route to market that could potentially benefit millions
of epilepsy patients worldwide.

 

-Ends-

 

Authorised for release by the board of directors, for further information
please contact:

 

 Argent BioPharma                                             Argent BioPharma

 Roby Zomer                                                   Rowan Harland

 CEO & Managing Director                                      Company Secretary

 +61 8 6555 2950                                              +61 8 6555 2950

 info@argentbiopharma.com (mailto:info@argentbiopharma.com)   info@argentbiopharma.co (mailto:info@argentbiopharma.co.uk) m

 

About Argent BioPharma

 

Argent BioPharma Limited (the "Company") (ASX: RGT; LSE: RGT; OTCQB: RGTLF) an
innovative multidisciplinary drug development Company within the
biopharmaceutical sector.  The Company focuses on multidisciplinary methods
with Nanotechnology, developing multi-target therapies for comprehensive
disease management, especially concerning the central nervous system ("CNS")
and Immunology treatments.

 

Follow us through our social media channels:

LinkedIn: Argent BioPharma

Twitter: @ArgentBioPharma

Facebook: Argent BioPharma

 

 

 

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